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Trial record 30 of 61 for:    "Lung Disease" | "Iloprost"

Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT02238535
Recruitment Status : Unknown
Verified September 2015 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : September 12, 2014
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief Summary:
To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Residual Pulmonary Hypertension Drug: Ventavis Drug: Warfarin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Study Start Date : September 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ventavis + Warfarin
Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0
Drug: Ventavis
Drug: Warfarin
Active Comparator: Warfarin
Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)
Drug: Warfarin



Primary Outcome Measures :
  1. Pulmonary hypertension [ Time Frame: 6 months ]
    The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).


Secondary Outcome Measures :
  1. Number of deaths [ Time Frame: 6 months ]
  2. Number of recurrent pulmonary embolisms [ Time Frame: 6 months ]
  3. Number of venous thromboembolisms [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
  • Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg

Exclusion Criteria:

  • Patient did not sign the informed consent.
  • Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
  • Age above 75 years.
  • Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
  • Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
  • Acute heart failure or CHF IV in NYHA.
  • Severe arrhythmias.
  • Pregnancy, lactation.
  • The presence of severe diseases of other organ systems that may result in death during the first year after surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238535


Contacts
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Contact: Yulia Klevanets, MD +79139443607 klevanetc@yandex.ru

Locations
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Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Yulia Klevanets, MD    +79139443607    klevanetc@yandex.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

Additional Information:
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02238535     History of Changes
Other Study ID Numbers: Ventavis_PRPH
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Lung Diseases
Iloprost
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants
Platelet Aggregation Inhibitors
Vasodilator Agents